A Quantified Internal Audit System Allowing Quality Rating of Clinical Research

Quality Control is applied at all levels of data generation and transfer in order that the study report will be a reliable and correct reflection of that experienced by the patient population in a given clinical study. In addition to on-site audits aimed at ensuring that the investigator fulfills his/her responsibilities, a Clinical Research Organisation (CRO) should demonstrate to the pharmaceutical industry that internal Quality Control is permanent within its normal operations. A CRO should be able to demonstrate a validated internal audit system, in addition to being transparent in its operations and generating a documented trail of each study. This article describes the establishment and integration of such a system into our company, the methods employed, and also presents preliminary results.